Outcomes of Patients with COPD Treated with ICS/LABA Before and After Initiation of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).

Triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) has been shown to improve symptoms and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. This real-world study compared exacerbation rates and healthcare resource utilization (HCRU) before and after initiation of FF/UMEC/VI in patients with COPD previously treated with inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). This retrospective cohort study included commercial and Medicare Advantage with Part D administrative claims data from September 01, 2016, to March 31, 2020, of patients diagnosed with COPD. The index date was the date of the first FF/UMEC/VI claim (September 2017-March 2019). The 12 months prior to index (baseline) were used to assess patient characteristics and outcomes; the 12 months following index (follow-up) were used to assess study outcomes. All patients had ≥ 30 consecutive days' supply of any ICS/LABA dual therapy during the 12 months prior to FF/UMEC/VI initiation. Subgroup analyses included patients with ≥ 30 consecutive days' supply of budesonide/formoterol (BUD/FORM) during baseline. Analyses of patients with ≥ 1 COPD exacerbation during baseline were reported as well. The overall population included 1449 patients (mean age 70.75 years; 54.18% female), of whom 540 were patients in the BUD/FORM subgroup. Significantly fewer patients experienced any exacerbation during follow-up versus baseline (overall population 53.49% vs 62.59%; p < 0.001; BUD/FORM subgroup 55.00% vs 62.41%; p = 0.004). Effects on exacerbation reduction were more pronounced among patients with ≥ 1 exacerbation during baseline. Lower COPD-related HCRU was observed during the follow-up compared with baseline for both the overall population and the BUD/FORM subgroup. Patients with COPD treated with ICS/LABA during baseline, including patients specifically treated with BUD/FORM and those with a history of ≥ 1 exacerbation, had fewer COPD exacerbations and lower COPD-related HCRU after initiating FF/UMEC/VI.

McCormack M ，Paczkowski R ，Gronroos NN ，Noorduyn SG ，Lee L ，Veeranki P ，Johnson MG ，Igboekwe E ，Kahle-Wrobleski K ，Panettieri R ... -  《-》

Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Triple Therapy Compared with Other Therapies for the Treatment of COPD: A Network Meta-Analysis.

Randomized controlled trials (RCTs) comparing triple therapies (inhaled corticosteroid [ICS], long-acting β2-agonist [LABA], and long-acting muscarinic antagonist [LAMA]) for the treatment of chronic obstructive pulmonary disease (COPD) are limited. This network meta-analysis (NMA) investigated the comparative efficacy of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus any triple (ICS/LABA/LAMA) combinations and dual therapies in patients with COPD. This NMA was conducted on the basis of a systematic literature review (SLR), which identified RCTs in adults aged at least 40 years with COPD. The RCTs compared different ICS/LABA/LAMA combinations or an ICS/LABA/LAMA combination with any dual therapy (ICS/LABA or LAMA/LABA). Outcomes of interest included forced expiratory volume in 1 s (FEV1), annualized rate of combined moderate and severe exacerbations, St George's Respiratory Questionnaire (SGRQ) total score and SGRQ responders, transition dyspnea index focal score, and rescue medication use (RMU). Analyses were conducted at 24 weeks (primary endpoint), and 12 and 52 weeks (if feasible). The NMA was informed by five trials reporting FEV1 at 24 weeks. FF/UMEC/VI was statistically significantly more effective at increasing trough FEV1 (based on change from baseline) than all triple comparators in the network apart from UMEC + FF/VI. The NMA was informed by 17 trials reporting moderate or severe exacerbation endpoints. FF/UMEC/VI demonstrated statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus single-inhaler budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR). At 24 weeks, the NMA was informed by five trials. FF/UMEC/VI showed statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus UMEC + FF/VI and BUD/GLY/FOR. FF/UMEC/VI also demonstrated improvements in mean SGRQ score versus other triple therapy comparators at 24 weeks, and a significant reduction in RMU compared with BUD/GLY/FOR (160/18/9.6). The findings of this NMA suggest favorable efficacy with single-inhaler triple therapy comprising FF/UMEC/VI. Further analysis is required as additional evidence becomes available.

Ismaila AS ，Haeussler K ，Czira A ，Youn JH ，Malmenäs M ，Risebrough NA ，Agarwal J ，Nassim M ，Sharma R ，Compton C ，Vogelmeier CF ，Han MK ，Halpin DMG ... -  《-》

Outcomes Following Initiation of Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol versus Multiple-Inhaler Triple Therapy Among Medicare Advantage with Part D Beneficiaries and Those Commercially Enrolled for Health Care Insurance in the Uni

Bogart M ，Bengtson LGS ，Johnson MG ，Bunner SH ，Gronroos NN ，DiRocco KK ... -  《International Journal of Chronic Obstructive Pulmonary Disease》

Clinical and Economic Evaluation of Fluticasone Furoate/Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol Therapy in Maintenance Treatment-Naive Patients with COPD in the US.

Long-acting bronchodilator (LABD) therapy is recommended for maintenance treatment in most patients with chronic obstructive pulmonary disease (COPD). However, triple therapy (TT; dual LABDs + inhaled corticosteroid [ICS]) is often used as first-line maintenance treatment. The benefits of TT versus dual LABDs as first-line treatments are unknown, necessitating an evaluation of its effectiveness and costs versus non-ICS alternatives. This retrospective study assessed administrative claims of maintenance treatment-naive patients in the United States with COPD aged ≥40 years initiating single-inhaler fluticasone furoate+umeclidinium+vilanterol (FF+UMEC+VI) or tiotropium+olodaterol (TIO+OLO). Patients were propensity score-matched (1:1) and followed for up to 12 months. The primary outcome was time to first COPD exacerbation. Secondary outcomes included time to first pneumonia diagnosis, pneumonia-related hospitalization, healthcare resource utilization (HCRU), and costs. COPD exacerbation and pneumonia risk were assessed using Cox proportional hazards regression. A total of 5,121 and 3,996 patients met the eligibility criteria for the FF+UMEC+VI and TIO+OLO groups, respectively. Outcomes were assessed among 2,951 matched pairs. The risk of moderate or severe COPD exacerbation was not significantly different between FF+UMEC+VI and TIO+OLO groups (hazard ratio [HR] [95% confidence interval {CI}]: 1.13 [0.99-1.29]; P=0.064). The risks of pneumonia (HR [95% CI]: 1.04 [0.85-1.27]; P=0.723) and pneumonia-related hospitalization (HR [95% CI]: 1.18 [0.78-1.79]; P=0.429) were also not significantly different between the groups. There were no significant differences in HCRU events or all-cause costs; however, FF+UMEC+VI initiators incurred greater COPD- and/or pneumonia-related pharmacy costs than TIO+OLO initiators (FF+UMEC+VI: $2,934 [$2,827-$3,041], TIO+OLO: $1,994 [$1,915-$2,073]; P<0.001). In maintenance treatment-naive patients, FF+UMEC+VI offered no reduction in COPD exacerbation risk over TIO+OLO and resulted in higher pharmacy costs related to COPD and/or pneumonia treatment. These results support treatment recommendations for LAMA+LABA as initial maintenance therapy. ClinicalTrials.gov identifier - NCT05169424.

Shaikh A ，Ritz J ，Casciano J ，Palli SR ，Clark B ，Dotiwala Z ，Quint JK ... -  《International Journal of Chronic Obstructive Pulmonary Disease》

Fluticasone Furoate/Umeclidinium/Vilanterol Initiation Following a COPD Exacerbation: Benefits of Prompt Initiation on COPD Outcomes.

Previous real-world evidence suggests that prompt versus delayed initiation of single-inhaler triple therapy (SITT) with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following an exacerbation results in improved clinical outcomes for patients with chronic obstructive pulmonary disease (COPD). This prior study was conducted in the first 2 years following FF/UMEC/VI approval, representing early trends. The current updated analysis aims to further elucidate the real-world evidence for FF/UMEC/VI. This was a retrospective cohort study using the IQVIA PharMetrics® Plus database. Patients with COPD initiating SITT with FF/UMEC/VI within 6 months of an exacerbation (index date) were classified as prompt (≤ 30 days following exacerbation) or delayed (31-180 days) initiators. The baseline period comprised the 12 months prior to index. Inverse probability of treatment weighting was used to balance differences in baseline characteristics between cohorts. COPD exacerbations, hospital readmission rates, and healthcare costs were compared between cohorts post-index. Overall, 5421 patients (prompt, 2057; delayed, 3364) were included. After weighting, baseline characteristics were well balanced between cohorts. For up to 12 months post-index, prompt initiators of FF/UMEC/VI had significantly lower rates of exacerbations per person-year versus delayed initiators (0.74 vs. 1.06; rate ratio 0.70, 95% confidence interval [CI] 0.64-0.77; P < 0.001). A 1-day delay in FF/UMEC/VI initiation was associated with a 0.31% increase in the rate of exacerbations. At 90 days post-index, Kaplan-Meier rates of all-cause (hazard ratio [HR] 0.62, 95% CI 0.45-0.86; P = 0.004) and COPD-related (HR 0.58, 95% CI 0.35-0.98; P = 0.042) hospital readmissions were significantly lower in the prompt versus delayed cohort. Total COPD-related healthcare costs per person per year were significantly lower for patients in the prompt versus delayed cohort. Healthcare providers should consider the positive impact of prompt FF/UMEC/VI initiation on exacerbation rate, hospital readmission rate, and costs when treating patients with COPD at risk of exacerbations.

Mannino D ，DiRocco K ，Germain G ，Laliberté F ，Noorduyn SG ，Urosevic A ，Paczkowski R ... -  《-》